Adjuvant chemotherapy of recurrent superficial transitional cell carcinoma: results of a European organization for research on treatment of cancer randomized trial comparing intravesical instillation of thiotepa, doxorubicin and cisplatin. The European Organization for Research on Treatment of Cancer Genitourinary Group.

A total of 356 patients with recurrent superficial transitional cell carcinoma of the bladder was entered in a randomized clinical trial to compare intravesical thiotepa, doxorubicin and cisplatin with respect to the recurrence rate and disease-free interval. After complete transurethral resection of all visible lesions, the drugs were administered weekly for 4 weeks and monthly for 11 months. The recurrence rates per year were 0.50 for thiotepa, 0.54 for doxorubicin and 0.58 for cisplatin. Of 266 patients (mean followup 41 months) 35 reported an increase in T category and 19 of them had distant metastases. No association between treatment and progression was noted. Thus, there is no difference among treatments with respect to efficacy. However, severe anaphylactic reactions were observed in the cisplatin arm and chemical cystitis was more frequently reported in patients who received doxorubicin.

RCT Entities:   Population Interventions Outcomes